UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation for monitoring of the glucose concentration in the aqueous humor
Title of the study (Brief title)	Monitoring of the glucose in the aqueous humor
Region	Japan

Condition
Condition	Healthy adult volunteer
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Subject to healthy adult volunteers, the correlation between intravenous blood glucose levels and glucose levels in aqueous humor detected by a non-invasive glucose monitor device are evaluated. Simultaneously, the time lag of the glucose level change is examined between intravenous and in aqueous humor.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the correlation between intravenous blood glucose levels and glucose levels in aqueous humor detected by a non-invasive glucose monitor device
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Following more than 10 hours fasting, 75g glucose solution is orally administrated. The intravenous glucose concentration is evaluated by POCT. Simultaneously, the glucose level in aqueous humor is evaluated by a laser irradiation to the subjected eye ball soaked in the saline.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Subjects: Healthy volunteers Sex: Male and Female Age: 20 years-old or over Obtaining consent: by written consent forms
Key exclusion criteria	People who have abnormality in their eye balls or eye lids such as closed angle. Difficulty in obtaining consent from the participants their selves.
Target sample size	3

Research contact person
Name of lead principal investigator	Kazuno Negishi
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Email	fwic7788@mb.infoweb.ne.jp

Public contact
Name of contact person	Toshihide Kurihara
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	kurihara@z8.keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Fuji Xerox Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 18 Day
Anticipated trial start date	2016 Year 02 Month 18 Day
Last follow-up date	2017 Year 08 Month 28 Day
Date of closure to data entry	2017 Year 08 Month 28 Day
Date trial data considered complete	2017 Year 08 Month 28 Day
Date analysis concluded	2017 Year 08 Month 28 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 02 Month 18 Day
Last modified on	2017 Year 08 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024317